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Phase II study of temozolomide (TMZ) without radiotherapy in newly diagnosed glioblastoma multiforme (GBM) in an elderly population TMZ without radiotherapy may offer a safe, convenient, and efficient therapeutic alternative in elderly patients with newly diagnosed GBM.


Posted on: 05/26/2002

Phase II study of temozolomide (TMZ) without radiotherapy in newly diagnosed glioblastoma multiforme (GBM) in an elderly population

Oliver Chinot, M Barrie, E Frauger, H Dufour, J Palmari, D Braguer, J. C Peragut, P. M Martin, F. Grisoli, CHU Timone, Marseille, France.

Rationale: Treatment of GBM in the elderly remains a matter of debate. While survival in patients over 70 years of age is about 4–5 months, standard radiotherapy scheme requires particular compliance and is associated with cognitive impairment in this population. TMZ has proven efficacy for the treatment of malignant gliomas with a good safety profile.

Objective: To evaluate the efficacy and safety of TMZ as first-line chemotherapy, without radiotherapy in elderly patients with newly diagnosed GBM.

Study Design: From May 1999 to September 2001, patients with newly diagnosed GBM, over 70 years of age, Karnofsky performance status (KPS) of 60 or greater were enrolled in the phase II study. Treatment of TMZ 150–200 mg/m2 per day for 5 days in a 28-day cycle was administered until disease progression. No radiotherapy was used. Primary endpoint was overall survival (OS); secondary endpoints included progression-free survival (PFS) and toxicity.

Results: 32 patients were included (median age: 74 years; 60 KPS: 36%). Surgery consisted of gross total resection in 1 patient, partial resection in 5 patients, and biopsy only in 26 patients. Median OS (ITT analysis) was 6.5 months; median PFS was 5.6 months. 30 patients were assessable for response: 9 (30%) partial response, 13 stable disease, and 8 progressive disease were observed; the associated OS per response was 13.3, 6, and 4 months, respectively (p = 0.02). Based on KPS and/or MMS, 43% of patients were improved during treatment. Toxicity evaluated during 142 cycles was mild; NCI grade 3–4 toxicities per patient included thrombocytopenia (n = 2) and neutropenia (n = 3). No neurotoxicity was observed. Overall, compliance was good with delay in 13% and dose reduction in 10% of cycles.

Conclusion: TMZ offers a safe, convenient, and efficient therapeutic alternative in elderly patients with newly diagnosed GBM.
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